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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000036793
Receipt No. R000041924
Scientific Title Clinical data over long term with sitagliptin treatment for type 2 diabetes patients in our hospital
Date of disclosure of the study information 2019/05/19
Last modified on 2019/05/19

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Basic information
Public title Clinical data over long term with sitagliptin treatment for type 2 diabetes patients in our hospital
Acronym Clinical data over long term with sitagliptin treatment for type 2 diabetes patients in our hospital
Scientific Title Clinical data over long term with sitagliptin treatment for type 2 diabetes patients in our hospital
Scientific Title:Acronym Clinical data over long term with sitagliptin treatment for type 2 diabetes patients in our hospital
Region
Japan

Condition
Condition type 2 diabetes mellitus
Classification by specialty
Endocrinology and Metabolism
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Administration of sitagliptin is expected not only to improve blood glucose but also to have a renal protection effect. However, there are not many reports on the long-term effects of sitagliptin in Japan.Therefore, we explore the effects on glycemic control and renal protection effect in patients with type 2 diabetes treated with sitagliptin for more than 5years.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes HbA1c, Urinary albumin
Key secondary outcomes 1. Efficacy and safety of sitagliptin single use
2. Safety in the elderly
3. Safety of patients using insulin

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit
90 years-old >=
Gender Male and Female
Key inclusion criteria 1) Outpatients
2) over 20 years old
3) T2DM
4) eGFR over 30 mL/min/1.73 m2
5) Diet and exercise therapies are well performed
6) Patients who are suspected good-compliant
7) Understanding of the study procedures and agreement to participate in the study, by giving written informed consent
Key exclusion criteria 1) Patients suspected of having secondary diabetes (ex. endocrine disease, drug-induced or liver disease)
2) Females who are pregnant or who intend to become pregnant within the study
3) Severe hepatic disease, malignancy, a history of gastrectomy and/or positive for HIV
4) Contraindication with sitagliptin
5) Patient who disqualified from the study by the investigator for any reason other than given above.
Target sample size 300

Research contact person
Name of lead principal investigator
1st name Yasuhiro
Middle name
Last name Iijima
Organization Tokyo Medical University
Division name Department of Diabetes, Endocrinology and Metabolism
Zip code 160-0023
Address 6-7-1 Nishishinjuku, Shinjuku-ku, Tokyo
TEL 03-3342-6111
Email yasuhiro.iijima1203@gmail.com

Public contact
Name of contact person
1st name Yasuhiro
Middle name
Last name Iijima
Organization Manda Memorial Hospital
Division name Diabetes Center
Zip code 060-0062
Address Minami 2, Nishi 1, Chuo-ku, Sapporo
TEL 011-231-4032
Homepage URL
Email yasuhiro.iijima1203@gmail.com

Sponsor
Institute Manda memorial hospital
Institute
Department

Funding Source
Organization none
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Manda Memorial Hospital
Address Minami 2, Nishi 1, Chuo-ku, Sapporo
Tel 011-231-4032
Email yasuhiro.iijima1203@gmail.com

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 萬田記念病院(北海道)

Other administrative information
Date of disclosure of the study information
2019 Year 05 Month 19 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled 400
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status No longer recruiting
Date of protocol fixation
2018 Year 12 Month 01 Day
Date of IRB
2019 Year 04 Month 19 Day
Anticipated trial start date
2018 Year 12 Month 01 Day
Last follow-up date
2019 Year 04 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information This study examines the retrospective effectiveness of medical records from patients with type 2 diabetes mellitus during outpatient visits to our hospital who have been dosed with sitagliptin during 2009-2013. Evaluation items are determined on the basis of HbA1c, microalbuminuria, and progression of complications. Statistical analysis is performed on the obtained data to evaluate the effect. And we will consider the secondary effects from the following three points.
(1) Patients who continued to use sitagliptin alone, (2) elderly patients aged 65 years or older, and (3) patients with combined insulin

Management information
Registered date
2019 Year 05 Month 19 Day
Last modified on
2019 Year 05 Month 19 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041924

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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